BIOINTRAFIX 254625Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705013227), received between Jun 29, 2018 and Jan 5, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6) 2023 THE BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE ANCHOR WAS BROKEN OFF. CHANGED ANOTHER BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE AND TWO MILAGRO ADVANCE SCREW 10X30MM DEVICES TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452209 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6) 2023 THE BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE ANCHOR WAS BROKEN OFF. CHANGED ANOTHER BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE AND TWO MILAGRO ADVANCE SCREW 10X30MM DEVICES TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451830 ↗
• MalfunctionJun 15, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE BIO-INTRAFIX TAPERED SCREW, 8-10 MM X 30 MM DEVICE BROKE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139540 ↗
• MalfunctionJun 16, 2022Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING AN ACL (ANT.CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TAPERED SCREW, 8-10 MM X 30 MM ANCHOR DEVICE HAD A CRACK ON IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711210 ↗
• InjuryOct 8, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE BIOINTRAFIX 8-10MMX30MM TPRSCR WHEN IT WAS BEEN INSERTED INTO THE SHEATH IN THE TUNNEL. THE INTERNAL HEX THREAD WAS LOST BEFORE THE SCREW WAS SUNK TO THE CORTICES (ABOUT 3MM PROTRUDING BEYOND BONE SURFACE). SCREW COULD THEREFORE NOT BE ADVANCED OR REMOVED. EXPOSED TIP OF SCREW WAS OSTEOTOMED OFF AT THE LEVEL OF THE BONE. A STAPLE WAS ALSO USED IN THE TIBIA TO ENSURE A SECURE FIXATION OF THE GRAFT. BEFORE IT WAS SUNK INTO THE CORTICES. THEREFORE IT COULDN¿T GO FURTHER OR BE REMOVED AND IT HAD TO BE LOWERED OFF AT THE LEVEL OF THE BONE. A STAPLE HAD TO BE USED IN THE TIBIA TO ENSURE AND SECURE THE FIXATION OF THE GRAFT. A SURGICAL DELAYED OF 2 MINUTES WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Code Available; Not Applicable

  MAUDE report 9169156 ↗
• MalfunctionJan 28, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S BIOINTRAFIX TAPERED SCREW, 8-10 X 30MM BROKE UPON INSERTION INTO VERY HARD BONE. THE SALES REP REPORTED THAT THE IMPLANT CRACKED BUT DID NOT BREAK INTO SEPARATE PIECES AND WAS FULLY REMOVED FROM THE JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE IN THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP REPORTED THAT THE SURGEON WAS OFF AXIS. THE CUSTOMER DISCARDED THE COMPLAINT DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282651 ↗
• MalfunctionJun 29, 2018Crack; Crack

  THE SALES REP REPORTED THAT DURING AN ACL PROCEDURE THAT TWO OF HIS BIOINTRAFIX TAPERED SCREWS AND LARGE SHEATHS BROKE UPON INSERTION. THE SALES REP STATED THAT THE SURGEON HAD PREDRILLED THE HOLE AND DID NOT TAP THE DEVICES IN. THE SALES REP REPORTED THAT THE BONE QUALITY WAS VERY HARD AND HE BELIEVED THE SURGEON MAY HAVE BEEN OFF AXIS. THE SURGEON COMPLETELY REMOVED BOTH OF THE SCREWS AND SHEATHS AND COMPLETED THE PROCEDURE WITH A THIRD SIMILAR SET OF DEVICES WITH NO PATIENT CONSEQUENCES OR DELAY. THE DEVICES WERE ALREADY DISCARDED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51030, 1221934-2018-51031, AND 1221934-2018-51034

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652973 ↗
• MalfunctionJun 29, 2018Crack; Crack

  THE SALES REP REPORTED THAT DURING AN ACL PROCEDURE THAT TWO OF HIS BIOINTRAFIX TAPERED SCREWS AND LARGE SHEATHS BROKE UPON INSERTION. THE SALES REP STATED THAT THE SURGEON HAD PREDRILLED THE HOLE AND DID NOT TAP THE DEVICES IN. THE SALES REP REPORTED THAT THE BONE QUALITY WAS VERY HARD AND HE BELIEVED THE SURGEON MAY HAVE BEEN OFF AXIS. THE SURGEON COMPLETELY REMOVED BOTH OF THE SCREWS AND SHEATHS AND COMPLETED THE PROCEDURE WITH A THIRD SIMILAR SET OF DEVICES WITH NO PATIENT CONSEQUENCES OR DELAY. THE DEVICES WERE ALREADY DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652935 ↗